The global trade in falsified medicines is substantial and poses a huge threat to public health. Furthermore, it is apparent that falsified medicines are increasingly being sold to consumers online.
On 1 July 2015, new regulations aimed at assisting consumers with recognising the legitimacy of medicines sold online will come into force. Pharmacies and general retailers selling medicines online will be required to register with the UK Medicines and Healthcare Products Regulatory Agency ("MHRA") and will be recorded on the MHRA's public list of UK registered online retail sellers of medicine.
EU Falsified Medicines Directive 2011/62/EU
In July 2011, the EU adopted Directive 2011/62/EU (the "Falsified Medicines Directive") and it came into force on 2 January 2013. Its aims are to control and monitor both the quality and trade of medicines across the EU and to diminish the availability of falsified medicines within the EU.
In particular, the concept of the EU common logo was introduced by the Falsified Medicines Directive. This provided the European Commission with the legal foundation to create a common logo which, for the purposes of verification, is technically, electronically and cryptographically adequate.
Article 25 of the Falsified Medicines Directive states that:
"the public should be assisted in identifying websites which are legally offering medicinal products for sale at a distance to the public. A common logo should be established, which is recognisable throughout the Union…The Commission should develop the design for such a logo. Websites offering medicinal products for sale at a distance to the public should be linked to the website of the competent authority concerned."
Under the Falsified Medicines Directive, Member States were granted the ability to select their own requirements for compliance by retailers and pharmacies supplying medicines online.
The Falsified Medicines Directive also amends EU Directive 2001/83/EC on the Community code relating to medicinal products for human use ("Directive 2001/83/EC"), as regards the prevention of the entry into the legal supply chain of falsified medicinal products. In particular, Article 85c (3) was amended to state that "in order to harmonise the functioning of the common logo, the Commission shall adopt implementing acts."
EU Implementing Regulation 699/2014
On 24 June 2014, the European Commission adopted a model EU logo by way of Implementing Regulation 699/2014 (the "Implementing Regulation") which puts into effect Article 85c (3) of Directive 2001/83/EC. In the Annex to the Implementing Regulation a form of logo was specified. Member States had one year from the date of adoption of the Implementing Regulation to ensure that the logo was implemented.
UK implementation of the EU common logo
The current regulatory requirements under the UK medicines legislation state that a vendor of medicines needs to be legally entitled to sell the relevant medicines. In the UK, registered pharmacies can sell general sales list ("GSL") medicines, pharmacy medicines and prescription-only medicines, whereas general retailers are only permitted to sell GSL medicines.
In June 2015, the MHRA announced that from 1 July 2015, all online vendors of medicines to the general public are required to register with the MHRA, subsequent to which vendors will be displayed on the MHRA's list of UK registered online retail sellers. The new rules also dictate that any medicines sold online must be licensed in the purchaser's respective Member State.
In addition, there will be a mandatory requirement for registered sellers to display the European common logo on each webpage of the respective website that offers medicines for sale. The logo will contain a hyperlink to the registered seller's entry in the MHRA's list of registered online sellers. The use of the logo and hyperlink will aid consumers in verifying the authenticity of the medicines they intend to purchase.
In circumstances where a registered seller retails medicines through an alternative supplier's website, then the alternative supplier will be required to display the registered seller's EU logo on each relevant webpage selling the products in question.
The sanctions for selling medicines online without registering with the MHRA, and thereby failing to display the logo, is up to two years in prison and/or a fine.
The introduction of the EU common logo represents one of several measures introduced by the Falsified Medicines Directive to safeguard public health and strengthen protection for patients and consumers. It is likely that the pharmaceutical industry and various parties within the supply chain will be monitoring the rollout of the EU common logo scheme and assessing the impact it has on reducing the online sales and availability of falsified medicines to patients and consumers.
The MHRA's senior policy advisor has supported the latest measures from the EU by commenting that "the new logo scheme should provide people buying medicines online with the reassurance that they are buying from a legitimate site…buying from an unregistered site could mean you do not know what medicines you are getting, and you could even be damaging your health."